
CM4620 Injectable Emulsion Versus Supportive Care in Patients With Acute Pancreatitis and SIRS
Acute PancreatitisSystemic Inflammatory Response SyndromeThis open-label, dose-response study will evaluate the safety and efficacy of CM4620-IE in patients with acute pancreatitis and accompanying SIRS. The study will consist of two phases. The first phase will consist of 4 female and 4 male patients (cohorts 1 and 2, respectively), enrolled concurrently, randomized in a 3:1 ratio to receive CM4620-IE plus standard of care versus standard of care alone. Planned doses for first phase will be CM4620-IE 1.0 mg/kg on Day 1 and then 1.4 mg/kg on Days 2 - 4. The second phase will consist of 8 female and 8 male patients (cohorts 3 and 4, respectively), enrolled concurrently, randomized in a 3:1 ratio to receive CM4620-IE plus standard of care versus standard of care alone. Planned doses for second phase will be CM4620-IE 2.08 mg/kg on Days 1 and 2 and then 1.6 mg/kg on Days 3 and 4. Dose escalation to second phase would only occur if needed for efficacy reasons and if no events suggesting a safety signal would occur with higher dosing. The study is not powered for the analysis of study data with inferential statisitcs as the primary purpose of the study is to explore what endpoints would be most appropriate for future trials.

A Randomized Controlled Pilot Trial of Indomethacin in Acute Pancreatitis
Acute PancreatitisThis is a randomized, double-blind, placebo-controlled pilot trial seeking to evaluate the efficacy of rectal indomethacin in abrogating systemic inflammation and subsequently organ failure and mortality in patients with AP and positive SIRS score.

A Dose Ranging Study Evaluating Efficacy and Safety of NI-03
Chronic PancreatitisThe purpose of this study is to determine the safety and efficacy of NI-03.

Electroacupuncture for Acute Pancreatitis
Acute PancreatitisThis study aims to prove the efficacy of electroacupuncture (EA) for pain relief in patients with acute pancreatitis compared with conventional treatment. Patients diagnosed with acute pancreatitis will be enrolled after obtaining informed consents. They will be randomly assigned to EA 1, EA 2, or control group in a 1:1:1 ratio. All the enrolled patients will basically receive the conventional standard-of-care therapy for acute pancreatitis. Local electroacupuncture will be given in group EA 1, while local with distal electroacupuncture will be given in group EA 2, additionally. For the conventional therapy, first non-steroidal anti-inflammatory drugs will be administered; afterwards, if inadequately controlled, low-potency narcotic analgesics such as codeine and then high-potency narcotic analgesics such as morphine or meperidine will be given sequentially as required. The patients randomized to the EA 1 and 2 groups will undergo 1 session of electroacupuncture daily from day 1 until day 4, or until pain is resolved. The primary endpoint is the visual analogue scale (VAS) for pain on day 5. Secondary endpoints include daily VAS, requirement of analgesics, changes of inflammatory markers, and hospital days.

Early Goal-directed Volume Resuscitation in Severe Acute Pancreatitis
Acute PancreatitisAcute pancreatitis (AP) is a common disorder with rising incidence varying between 35 and 80 per 100,000 in Europe and the USA. About 15% of patients develop necrotizing pancreatitis (NP) with a mortality of up to 42% and frequently prolonged hospitalisation in the survivors. Despite a fulminant pathophysiology comparable to that of sepsis, the management of NP is still re-active, symptomatic and mainly based on paradigms with low grade evidence. In sepsis beneficial effects of early goal-directed fluid resuscitation resulting in reduced mortality have been clearly shown. With regard to these data and several studies of NP demonstrating the deleterious effects of fluid loss and haemoconcentration within the first 24h after admission, early goal-directed fluid resuscitation has the potential of improving outcome also in NP. Therefore, it is the aim of this RCT to demonstrate beneficial effects of early goal-directed resuscitation using an algorithm based on modern haemodynamic parameters such as Intra-thoracic Blood Volume Index (ITBI), Extravascular Lung Water Index (ELWI) and Stroke Volume Variation (SVV) which can be easily and safely obtained due to recent progress in haemodynamic monitoring. The algorithm is aimed at maintaining adequate resuscitation (ITBI, SVV) as well as preventing pulmonary over-hydration (ELWI).The use of a similar algorithm in cardiac surgery patients resulted in a significant reduction in catecholamine use, lactate levels, duration of ventilation and ICU stay.

Randomized Controlled Trial on Pancreatic Stent Tube in Pancreaticoduodenectomy
Pancreatic CancerBile Duct Cancer3 moreThe purpose of this study is to determine which stent type is effective in the decrease of postoperative stay and complications across pancreaticojejunostomy after pancreaticoduodenectomy.

Diclofenac for the Prevention of Post-ERCP Pancreatitis in Higher Risk Patients
PancreatitisInflammation of the pancreas (pancreatitis) is an uncommon but potentially serious complication of endoscopic retrograde cholangiopancreatography (ERCP), a specialized endoscopic examination of the ducts draining the liver and pancreas. Although many different strategies have been tried and studied in attempts to reduce this risk, few have been shown to make a significant difference. Those that have are either very expensive, difficult to administer, or both. Diclofenac, an anti-inflammatory medication most often used to treat arthritis, has shown potential to decrease the risk of post-ERCP pancreatitis. It can be given after the procedure to patients at most risk for the complication, and has few side effects. This study will randomize people in the study to placebo or active medication, to determine if Diclofenac reduces the incidence of pancreatitis.

Efficacy Study of Glyceryl-Trinitrate Patch and Parecoxib (Valdecoxib) for the Prevention of Pancreatitis...
ERCPPancreatitisERCP is a diagnostic and therapeutic procedure that is required in patients with suspected common bile duct stone, malignant biliary obstruction, biliary fistula, etc. Pancreatitis may occur as a complication of this procedure after about 5-10% of the ERCP procedures. This complication manifests as persisting pain 24 hours or more after ERCP, along with raised levels of pancreatic enzymes in the blood. Most of the cases of post-ERCP pancreatitis are mild, but may be severe and lead to prolonged hospitalization a few patients. The occurrence of this complication is unpredictable. There have been a number of attempts to prevent this complication. These include giving certain drugs before ERCP e.g. octreotide, somatostatin, steroids, etc. However, these have not been successful. Recently, a study showed that application of glyceryl trinitrate patch on the skin before ERCP might reduce the incidence of post ERCP-pancreatitis. Another study showed that per rectal administration of diclofenac tablet after the ERCP procedure also reduced occurrence of post ERCP pancreatitis. Other experimental studies have shown that certain anti-inflammatory drugs like cox-2 inhibitors may also be effective. The investigators want to study whether transdermal patch of glyceryl trinitrate or administration of injectable cox-2 inhibitor Valdecoxib (pro-drug Parecoxib) can prevent post-ERCP pancreatitis in our patients who undergo an ERCP.

Prospective Study of Celiac Block Injection: 1 vs. 2
Chronic PancreatitisPancreatic CancerThe purpose of this prospective randomized study is to compare the clinical effectiveness of EUS-guided CB performed with a single injection versus two injections of medication into the celiac ganglion region.

Impact on Outcome of Early Endoscopic Extraction of Bile Duct Stones in Biliary Pancreatitis
Biliary PancreatitisImpact on outcome of early endoscopic extraction of bile duct stones in biliary pancreatitis: a prospective multicenter randomized controlled study.